Compounded Preparations Monographs (CPMs)

USP Compounded Preparation Monographs contain formulations used in human and animal patients. These monographs provide quality standards for specific preparations to assist practitioners in compounding formulations for which there is no suitable commercially available product.

USP Compounded Preparation Monographs include the following:

Formulas (ingredients and quantities)

Directions to correctly compound the preparation

Beyond-use dates based on stability studies

Packaging and storage information

Acceptable pH ranges

Stability-indicating assays

These monographs appear in the USP–NF and in the USP Compounding Compendium. The monographs may be used by compounders to prepare specific formulations for patients for whom there are no suitable commercially available products. The monographs also contain important beyond-use date information on the formulation, which is the date after which the preparation must not be used.

Creating a USP Compounded Preparation Monograph

USP has provided compounded preparation monographs (CPMs) since 1820. The process of creating CPMs begins with identifying a public health need. USP applies the following criteria to prioritize formulas for development:

Medications with the highest public health impact (i.e., affecting major population groups, disease states, and access needs)

Medications essential to treat pediatric and geriatric patients where there are unmet needs

Medications that need to be formulated to avoid allergic reactions and to be suitable for administration to patients with specific genetic anomalies

Medications for currently unmet clinical and therapeutic needs.

Currently, there are two pathways for CPM creation. One path is for USP to initiate the creation of the data and evidence necessary for the monograph addressing a priority public health need. Since 2012, USP has invested more than $1.8M for the development of monographs to meet public health needs. The other path is via monograph donations. Here, information to support monograph development is provided by entities in academia, drug manufacturers and other stakeholders who may have the data necessary for the creation of a monograph. The data is then provided to the Compounding Expert Committee for analysis, further development, and approval. Once approved, the CPM is published in the USP–NF.